Kornimate/medical-research-clean huggingface dataset:
muscle elastography in spastic cerebral palsy

Conditions: Unilateral Spastic Cerebral Palsy

Summary: to date, clinical tests are unable to differentiate between the cause of muscle stiffness, although a manual instrumented spasticity assessment for the lower limb that utilizes surface electromyogram has recently been proposed. this study intends to use shear wave elastography to assess individual muscle stiffness parameters and the individual response to botulinum toxin injection in the elbow and wrist flexors. collection of baseline spasticity parameters could then be used to predict the effect of botulinum toxin type a and ultimately serve as a basis for development of a treatment model for muscle spasticity in patients with spastic cerebral palsy.


Eligibility criteria:
inclusion criteria: * patients with unilateral spastic cerebral palsy with presence of dynamic muscle spasticity in the elbow and/or wrist flexors, who will be able to provide consent. * consent may be obtained from a parent or legal guardian, as applicable. exclusion criteria: * prior surgical procedure in the affected upper extremity * unrelated orthopedic injury to the affected upper extremity * current oral or intrathecal antispasticity therapy * prior botulinum toxin type a injection in preceding 6 months
vorinostat in treating women who are undergoing surgery for newly diagnosed stage i -iii breast cancer

Conditions: Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer

Summary: this phase ii trial is studying how well vorinostat works in treating women who are undergoing surgery for newly diagnosed stage i, stage ii, or stage iii breast cancer. vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. giving vorinostat before surgery may shrink the tumor so that it can be removed.

primary objective: i. determine the safety and tolerability of vorinostat in women undergoing conventional surgery for newly diagnosed stage i-iii breast cancer. ouline: this is a multicenter, pilot study. patients receive oral vorinostat twice daily on days -3 to 0. approximately 2 hours after the final dose of vorinostat, patients undergo surgical resection of the tumor on day 0. after completion of study treatment, patients are followed for 30 days.

Eligibility criteria:
inclusion criteria: * no prior or concurrent hormonal therapy for breast cancer * histologically confirmed breast cancer, stage i-iii disease, scheduled to undergo definitive surgery or other primary treatment (e.g., preoperative/neoadjuvant systemic treatment) for breast cancer * ecog 0-2 or karnofsky 60-100% * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * bilirubin normal * ast and alt ≤ 2.5 times upper limit of normal * pt ≤ 14 seconds * creatinine normal * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no ongoing or active infection * no psychiatric illness or social situation that would preclude study compliance * no other uncontrolled intercurrent illness * no history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat * at least 30 days since prior hormone replacement therapy (e.g., estrogen and/or progestin) * concurrent vaginal hormone preparations (e.g., vagifem or estring) allowed * no concurrent birth control pills * no prior radiotherapy to the ipsilateral breast * no prior or concurrent radiotherapy for breast cancer * no prior or concurrent novel therapy for breast cancer * at least 14 days since prior valproic acid or another histone deacetylase inhibitor * no other concurrent investigational agents * no concurrent combination antiretroviral therapy for hiv-positive patients * no other concurrent therapy for this cancer * wbc ≥ 3,000/mm\^3 exclusion criteria: * patients must not be recieving any other investigational agents * history of allergic reactions attributed to compounds of similar chemical or biologic composition to saha. * patients may not be taking valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to initiating saha. * women who are pregnant.
study to determine interaction between the use of feminizing hormone therapy and antiretroviral agents concomitantly among transgender women

Conditions: PrEP and ART

Summary: objective 1. to determine pharmacokinetic (pk) ddi between gaht and arvs used as prep and art among tgw 2. to evaluate arv adherence among tgw

gaht will be initiated on week 0. arvs, either prep or art, will be initiated on week 3. gaht will then be withheld on week 5, and restart at week 8. gaht: oral estradiol valerate 2 mg once daily and cyproterone acetate 25 mg once daily, which are the treatment of choice for gaht in the trc-arc's tangerine community health center, will be provided to all participants. prep and art regimen: generic fixed-dose combination of tdf 300 mg and ftc 200 mg will be used for prep and a generic fixed-dose combination of tdf 300 mg, ftc 200 mg and efavirenz 600 mg will be used for art as recommended in the 2017 thailand national guidelines on hiv/aids treatment and prevention.

Eligibility criteria:
inclusion criteria: 1. thai nationality 2. age 18-40 years old 3. male-to-female transgender individual 4. prep/art naïve 5. body mass index 18.5-25 kg/m2 6. calculated creatinine clearance (crcl) ≥60 ml/min, as estimated by the cockcroft- gault equation 7. alanine aminotransferase (alt) ≤2.5 x uln 8. have signed the informed consent form exclusion criteria: 1. known history of allergy to hormonal or arv component to be used in the study 2. male-to-female transgender who underwent orchiectomy 3. any of the following in hiv-infected participants * cd4 \< 350 cells/mm3 * history of psychiatric disorder that may be worsening by taking efv 4. previous use of injectable gaht in the past 6 months 5. current use of any of the following medication: * anticonvulsant: phenytoin, carbamazepine or phenobarbitol * ergot-containing agents: dihydroergotamine, ergotamine or other ergot derivatives * sedatives: midazolam or triazolam * herbs: gingko biloba, st john's wort or milk thistle * anti-infective agents: erythromycin, clarithromycin, ketoconazole, itraconazole, rifampicin or rifabutin 6. alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
study of ammoxetine hydrochloride enteric-coated tablets in healthy subject

Conditions: Depression

Summary: this study evaluates the safety, tolerability and pharmacokinetics of ammoxetine hydrochloride enteric-coated tablets in chinese healthy subjects


Eligibility criteria:
inclusion criteria: * males and females age 18-45 years * body weight ≥ 45kg (female) or 50kg (male), 18 ≤ bmi ≤ 26 * vital signs, physical examinations and laboratory tests and other tests prove participants are healthy * sign the informed consent form voluntarily and cooperate voluntarily to complete the test exclusion criteria: * allergens (allergic to 2 or more drugs, food or pollen) * comorbid illness (mental illness, liver and kidney disease, gastrointestinal diseases, nervous system disease, or other systemic diseases) * have clinically significant abnormal screening laboratory values. * systolic pressure \> 140mmhg or diastolic \> 90 mmhg * postural hypotension (systolic blood pressure drop by 20mmhg or diastolic blood pressure drop by 10mmhg after standing position) * the qtc period ≥ 450ms (male) or 470ms (female) or has a history of qtc extension * smoking or alcohol consumption (14 units per week in the previous 4 weeks : 1 unit = beer 285ml, or 25ml of spirits, or 150 ml of wine; daily smoking ≥ 5) or abusing in past year of drug and other substance * have donated or lost blood 400 ml within 8 weeks prior to screening * participated in other clinical trials within 3 months prior to screening * intakes too much caffeinated beverage or food within 4 weeks prior to screening. such as: coffee, tea, chocolate, cola, red bull (no more than 6 units per day). 1 unit of caffeine = 1 cup of coffee (177.4 ml) = 2 pots of cola (354.9 ml) = 1 cup of tea (354.9 ml) = 1/2 cup energy drink = 85g chocolate * have taken drugs that changed liver enzyme activity, such as dexamethasone, ketoconazole, rifampicin and omeprazole, were used within 4 weeks prior to screening * have taken prescription drugs and otc (except for the occasional use of acetaminophen and nasal sprays), herbs vitamins or minerals within 4 weeks prior to screening. the interval from prior treatment to screening should be at least 5 half-lives metablism which subjected to the longer halflife * using any psychotropic drug or psychoactive substance * women were screened for positive blood pregnancy * the subjects and their partners were not willing to take contraceptives during trial and six months after the study * have a donor plan recently * have participated in this trial * the researchers believe that anyone who is unfit to participate in this test will be involved
effects of antarctic environment on vitamin d status and health risk biomarkers of its inhabitants

Conditions: Vitamin D Deficiency

Summary: the purpose of this study is to evaluate vitamin d (vd) deficiency in the population of chilean antarctica and evaluate the efficacy and safety of vd supplementation to decrease vd deficiency and favorably influence biomarkers for bone, cardiovascular, and immune health risk in the inhabitants of chilean antarctica.

the present study consists of an initial cross-sectional evaluation of vd status and specific health biomarkers in inhabitants of chilean antarctica, followed by a randomized controlled trial evaluating two acceptable approaches of vitamin d supplementation (cholecalciferol 600 iu daily vs. 25000 iu weekly) in antarctic inhabitants.

Eligibility criteria:
inclusion criteria: * population of all ages living in the chilean antarctic territory during at least 3 months. exclusion criteria: * acute or chronic renal disease * hyper or hypocalcemia * osteomalacia or paget's disease of bone * use of vd supplements or fish oil supplements in the past month in doses higher than 400 iu daily * treatment for known vd deficiency in the last 6 months * uv phototherapy in the past month.

Keywords: vitamin d cholecalciferol antarctica chile cathelicidin bone metabolism cardiovascular risk
efficacy assessment of two antibiotic prophylaxis regimens in oral and maxillofacial trauma surgery

Conditions: Facial Fractures

Summary: the study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the oral and maxillofacial surgery and traumatology services of the onofre lopes university hospital attached to the federal university of rio grande do norte.

the study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the oral and maxillofacial surgery and traumatology services of the onofre lopes university hospital attached to the federal university of rio grande do norte.this clinical study was prospective, randomized and controlled. patients underwent surgery for facial fracture reduction and fixation under general anesthetic. prior to surgery, patients were randomly divided into two groups. group 1 patients each received 2g of cefazolin (cefazolin sodium - ampoule- 1g - genéricos brasil), administered intravenously but none was administered in the post-operative period. group ii patients received the same dose prior to the operation but in the post-operative period they also received 4 additional 1 g doses of cefazolin intravenously, completing a 24 period of antibiotic prophylaxis. in the case of operations that lasted for more than 4 hours, an additional 1g dose was given. the surgical operations involved intra and extra-oral interventions and when required internal rigid fixation was undertaken using titanium plates and screws. patients were given advice on oral hygiene procedures to be followed in the post-operative period that included chlorhexidine (0.12%) oral rinses and care to be taken with the surgical wounds. post-operative follow up was conducted in the 1st, 2nd, 4th and 6th weeks. the criteria used to determine the presence of infection were: a) pus drainage at the fracture site or in the vicinity of the surgical intervention site; b) increased swelling 7 days after the operation; c) presence of a fistula in the area of the surgical intervention or at the site of the fracture, with active drainage; d) other clinical features observed by the evaluator including typical signs of infection such as fever, edema, and localized redness. descriptive analysis was made of the independent variables, namely, age, sex, presence of systemic diseases, trauma cause, drug use (tobacco, alcohol, marijuana, crack, cocaine , etc.), the time lapse between the trauma event and the surgical operation, length of the operation, and the measures adopted when infections were detected.

Eligibility criteria:
inclusion criteria: * both genders * asa i, ii, iii * have facial fractures, that request surgical treatement, and whitout infection exclusion criteria: * patients with pan-facial fractures * or requiring surgery longer than six hours

Keywords: postoperative infection antibiotic prophylaxis cefazolin
phase 1 and phase 2 clinical trials of snubh-nm-333(18f)

Conditions: Alzheimer Disease

Summary: to evaluate pharmacokinetics, safety and efficacy of snubh-nm-333(18f), a new diagnostic radiopharmaceutical for pet imaging of amyloid plaques, in alzheimer's disease patients and healthy volunteers.

the investigators will perform whole-body and brain kinetic modeling of snubh-nm-333(18f) and optimize the image acquisition procedure. five young healthy subjects will be participated in whole-body positron emission tomography /computed tomographic (pet/ct) scans from the midfemoral position to the head after approximately 5-10 mci of snubh-nm-333(18f) injection. for brain pet/ct amyloid imaging, another five young healthy subjects will be scanned dynamically during windows of 0-180 min after injection of snubh-nm-333(18f), with arterial sampling. the investigators will compare different analysis methods of compartmental modeling and standardized uptake value ratios and determine the optimal acquisition window. and then 10 ad patients and 10 elderly healthy controls will also be participated in brain amyloid imaging to compare snubh-nm-333(18f) brain retention in ad patients versus healthy elderly.

Eligibility criteria:
inclusion criteria: * healthy young controls who are 20 - 30 years old and have no subjective memrory complaints * cognitively normal elderly who have clinical dementia rating score of 0 * alzheimer's disease (ad) patients who met both the dsm-iv criteria for dementia and nincds-adrda criteria for probable ad exclusion criteria: * any present serious medical, psychiatric, or neurological disorder that could affect mental function; evidence of focal brain lesions on mri; the presence of severe behavioral or communication problems

Keywords: amyloid plaque positron-emission tomography radiopharmaceuticals
optimized treatment and regression of hbv-induced compensated liver cirrhosis

Conditions: Liver Cirrhosis

Summary: six hundreds patients with chronic hepatitis b clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. one arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.patients will be assessed at baseline, at every six months for blood cell count, liver function test, hbvdna, afp, prothrombin time, liver ultrasonography, and fibroscan;


Eligibility criteria:
inclusion criteria: 1. patients from age 18 to 65 years ; 2. male or female; 3. treatment-naive patients of clinically diagnosed as hbv-induced compensated cirrhosis(meet one of the following two criterions); 1. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension 2. if no endoscopy,should meet two of the four criterias: * imaging (us, ct or mri, et al) showing surface nodularity: echogenecity * platelet (plt) \ /l , no other interpretation * albumin (alb) \ 1.3 (prothrombin time (pt) prolonged \> 3s), or cholinesterase (che) decrease * liver stiffness measurement value \> 12.4 kpa (alt\<5×uln) 4. hbeag-positive, hbvdna \> 2×10\ iu/ml or with hbeag-negative patients, hbvdna \> 2×10\ iu/ml; 5. agree to be followed up regularly; 6. signature of written inform consent. exclusion criteria: 1. patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma; 2. patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for medicine in this study; 3. patients with hcv or hiv infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases; 4. patients with baseline afp level higher than 100ng/ml and possible malignant lesion on image, or afp level higher than 100ng/ml for more than three months; 5. creatinine \> 1.5×uln; 6. patients with other uncured malignant tumors; 7. patients with severe diseases of heart, lung, kidney, brain, blood system or other organs; 8. patients with any other reasons not suitable for the study.

Keywords: liver cirrhosis hepatitis b compensation efficacy
virtuos bone graft in lumbar fusion

Conditions: Degenerative Disc Disease

Summary: a post-market open label study to assess the efficacy of a cellular based allograft bone graft in lumbar spinal fusion at one or two levels

single arm prospectively enrolled observational study of subjects who undergo lumbar spinal fusion at one or two levels with an anterior or lateral surgical approach using a cellular based allograft (virtuos) as the bone graft there is no experimental intervention for this study. subjects will be treated per standard of care by their attending physician/surgeon. the primary endpoint in this study is fusion success at 12 months. as determined by the attending physician/surgeon using ct as the imaging modality. the fusion rates observed at 12-months will be compared to an historical group of patients that underwent a one or two level lumbar fusion procedure with an anterior or lateral approach using a cellular based allograft (trinity elite).

Eligibility criteria:
inclusion criteria: subject must be 18 years of age (≥ 18 years) or older at the time of consent. * subject must undergo lumbar interbody fusion study at 1-2 contiguous levels. * virtuos must be the primary bone graft (≥ 50% of the total graft volume) and may be augmented with autograft or cortical or cancellous bone chips. * subject must be willing and able to sign an informed consent document. * subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations, and comply with the required study protocol.- exclusion criteria: * subject is under 18 years of age (\<18) at the time of consent. * subject has had prior lumbar spine fusion surgery at any level. * subject has greater than grade 1 spondylolisthesis of the lumbar spine. subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted) * subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection

Keywords: lumbar spinal fusion cellular based allograft anterior lumbar interbody fusion (alif) lateral lumbar interbody fusion (llif)
functional capacity through hrv in multimodal rehabilitation for adult surgery

Conditions: Frailty in Adult Surgery

Summary: this prospective, observational cohort study investigates heart rate variability (hrv) monitoring using the analgesia nociception index (ani) monitor in adult patients undergoing major surgery within a multimodal rehabilitation program. the objective is to correlate hrv indices with functional capacity, physiological reserve, and frailty during the prehabilitation phase.

the study evaluates hrv using the ani monitor to determine adaptation to training load, optimize analgesic and anesthetic dosing, and predict postoperative complications. the hrv indices of energy (sdnn) and ani (hfnu) are monitored at two points: the initial pre-anesthesia consultation and one week before surgery. results will be compared with the 6-minute walk test, must nutrition screening scale, and clinical frailty and frail scales.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age * scheduled for major adult surgery * any asa classification * signed informed consent exclusion criteria: * urgent surgery * severe cognitive impairment * patient refusal to participate * pediatric patients * cardiac arrhythmia or atrial fibrillation

Keywords: heart rate variability, prehabilitation, major surgery, frailty, physiological reserve
is there effect of adding honey intake to free walking in metabolic syndrome children

Conditions: Metabolic Syndrome

Summary: metabolic syndrome is common in children and complementary therapies are important in its treatment such exercise and functional food intake including honey.

forty children with metabolic syndrome will assigned to group of free walking continuous exercise (thirty minutes daily in nearby sport club in the presence of their parents and walking was supervised by authors via videoconferencing imo program) and this group also will receive healthy dietary guidelines in addition to consuming natural honey for 12 weeks.. the other group that will contain 20 patients will take only free walking exercise and healthy diet guidelines for 12 weeks.

Eligibility criteria:
inclusion criteria: * 40 metabolic syndrome children exclusion criteria: * respiratory, cardiac , renal , liver problems